Field of the Invention and Related Art
Enlargement or enhancement of tissue and especially soft tissue on a person's body is often desirable and may also be necessary to correct abnormalities or improve healing. The improvement or enlargement of breast tissues is an example of one such enlargement.
A safe non-invasive method of soft tissue enlargement, such as breast enhancement, is needed. A safe method and/or apparatus is necessary, especially after the recent problems with implants.
There has long been an understanding of how soft tissue enlargement can occur in nature, i.e., the expansion of the skin during pregnancy and other parts of body accommodate internal growth including subcutaneous growths, as well as weight loss and/or gain.
Prior art devices and methods include surgical techniques, including insertion of balloons and pins for limb lengthening. A thorough review of this prior art is set forth in U.S. Pat. No. 5,536,233 as the basis for the improvement described therein. The generalized method and apparatus described in U.S. Pat. No. 5,536,233 is an improvement over the prior art and describes the basis for the improved invention described hereon.
The prior art has disclosed that the soft tissue enlargement by means of vacuum should occur. However, the prior art did not describe apparatus or vacuum valve which would provide the controlled tissue enlargement on various parts of the body. This invention produces a permanent enhancement of tissue, especially soft tissue, without surgical or other deleterious effects on the patient.
The prior art describes the use of a vacuum to produce soft tissue enlargement. As noted in U.S. Pat. No. 5,536,233, the prior art failed to achieve long term soft tissue enlargement without damage to the soft tissue being enlarged, as well as the surrounding tissue. This damage to the surrounding tissue has limited the amount of vacuum which may be applied to the soft tissue for purposes of enhancement or enlargement. The prior art U.S. Pat. No. 5,536,233 has attempted to avoid this damage to surrounding tissue by the use of a rim around the periphery of the dome to which the vacuum is applied. This rim is described as having sufficient surface area so that the pressure applied by the rim is less than or equal to the negative pressure applied to the soft tissue under the dome. By regulating the pressure within the dome to 11/2 inches of Mercury (Hg), the damage to the soft tissue is avoided by use of the rim. The prior art is limited to a vacuum with a magnitude of less than 11/2 inches of Hg which limits the enhancement.
This invention overcomes that limitation of limiting the pressure which may be utilized for cell enhancement by diffusing, by a novel seal, the excessive pressures that previously would have been applied to the surrounding tissue causing contusions and/or tissue damage.
The normal animal cell, including that of humans, has in general a predefined shape and size. It has been discovered when sufficiently stressed, the cell will increase in size and its external structure will also deviate to accommodate any vacuum or negative force that is applied to the cell. Proper application of vacuum to the cellular structure can induce the cell to replicate and/or accommodate the stress that is applied by the vacuum. The resiliency of cellular membranes and its supporting structure, as noted in the prior art and as discovered in the use of this invention, can be damaged beyond repair by the application of an excessive amount of vacuum. Therefore, it is critical that the amount of vacuum be controlled and limited to avoid damage to the cells, including internal mechanisms and membranes, being subjected to the vacuum as well as the cells in the surrounding tissue. This invention has shown that animal cellular structures can accommodate vacuums from 0.0009 inches of Hg to 15 inches of Hg without destruction of tissue, if properly applied. Above 15 inches of Hg massive destruction of healthy cells occurs. It has been shown that total destruction of the cell membrane and the nucleus by stretching or elongating beyond its physical limits will destroy these cells. Observation indicates that unhealthy cells being less resilient will be destroyed at different pressures so regeneration is not possible as with healthy cells. This may have positive health benefits due to destruction of unhealthy cells and enhancement of healthy cells. Unhealthy cells will destroy at any pressure and care must be taken not to apply even small amounts of vacuum to unhealthy cells. In general, vacuums of above 15 inches of Hg are necessary to destroy most soft tissue cells. However, a dramatic rapid rise in vacuum (decompression) from 0-8 inches of Hg may cause massive cellular damage as exhibited by bruises and contusions.
The body's system can routinely repair most, if not all, damage caused by light to medium amounts of vacuum. This is similar to the repair of minor contusions, discoloration and vascular seepage caused by small amounts of vacuum such as that which can be applied to the skin by the vacuum induced by the mouth. It has been found that the optimum pressure or the optimum vacuum in inches of Hg necessary to produce the desired affect of inducing cellular reproduction or enlargement and the enlargement or enhancement of soft tissue is 10 inches of Hg.
As a result of experiments utilizing this invention it has been recorded that each new generation of cellular growth or enhancement improves the elasticity and toughness of the cell membranes. Observations of the experiments of applicant indicate that the longer cell structure is stressed by applying 25-75% of the safe maximum vacuum in inches of Hg over an extended period of time, new cellular growth is stronger in structure and more resilient. It has also been shown from the experiments that the greater the negative vacuum or pressure up to 10 inches of Hg, that is applied, result in firmer enhanced tissue in a shorter time.
If this method and apparatus is used, i.e., a vacuum of 1-9 inches of Hg, at the beginning of the enhancement process small and superficial contusions or bruising will occur. It has been determined that the comfort level of vacuum should be gradually increased over a period of time, starting from approximately 1-11/2 inches of Hg and proceeding to higher values of vacuum to 8.5 to 9 inches maximum. The apparatus upon which tests were conducted would create a vacuum of 10 inches of Hg. This maximum amount is reduced from 10 inches of Hg for the safety affect.
This invention has also been utilized with variations in the configuration of the dome, sphere, or shape of a vacuum applicator and/or containment vessel. Varying the shape of the vacuum applicator varies the forces exerted upon the material or tissue enclosed in the sphere. Thus, the tissue may be elongated, lengthened, or widened by enhancement or expansion within the sphere.
It has also been discovered in the use of the invention that the more tissue under and in proximity to the dome increases the suction force and the rate of enlargement.
Thus, this invention provides for a plurality of vessels or domes with various configurations to control the direction and the rate of cellular enhancement or enlargement.
The vacuum force acts to cause the veins and arteries to engorge carrying with the benefits of increased blood flow which is a beneficial side affect provided by this invention in conjunction with the enlargement. Although this invention has not been utilized, except to produce new and enhanced or enlarged soft tissue structures, it is believed that other uses of vacuum pressure to induce cellular growth would be useful in other areas. This would require the development of new vessels or instruments which could enclose the area or tissues to be repaired while not damaging the surrounding tissue. The increase in blood flow, due to enlargement of blood vessels, would improve the cells and provide more nutrients to damaged areas such as burns. It also may be useful in muscle development and bone tissue development in both gravity and zero (0) gravity environments or would appear to be useful on most any tissue that has morphotic characteristics.
As noted above, the prior art devices have failed to achieve long term soft tissue enlargement while preventing damage to the soft tissue being enlarged, as well as any surrounding tissue. These prior art devices have not been successful because the amount of vacuum necessary to provide successful enlargement of the soft tissue has not been able to be achieved without damage to surrounding tissue. The low vacuum pressure described in the prior art does not provide for adequate enhancement or enlargement of the soft tissue because the amount of pressure was limited by the ability of the device to prevent damage to the surrounding tissue.
This invention allows the use of a method of enclosing soft tissue within a containing device, applying a substantial vacuum to the soft tissue. The downward force of the vacuum is absorbed by the novel seal without damage to the surrounding tissue against which the container reacts. The invention is able to use a vacuum pressure which will enlarge soft tissue at greater pressures than prior art devices.
The novel seal and force diffuser between the vacuum container and the human cells or tissues surrounding the tissues to be enhanced permits the use of a vacuum force which will stimulate cell activity without permanent harm to cells and/or user.